Randomised controlled trial to determine the benefit of daily home-based exercise in addition to self-care in the management of breast cancer-related lymphoedema: a feasibility study

Abstract

Exercise is considered to be a key aspect of lymphoedema treatment, although there is little evidence for the therapeutic effect of exercise in managing breast cancer-related lymphoedema (BCRL). This small randomised controlled trial (RCT) was designed to determine the feasibility, prior to undertaking a larger RCT, of researching a daily home-based exercise programme to treat stable BCRL. An experimental design compared the exercise intervention combined with standard lymphoedema self-care to self-care alone over a 6-month period. Twenty-three women with stable unilateral BCRL of ≥10 % excess limb volume (ELV) were randomly allocated to a daily home-based exercise programme and self-care (n = 11) or self-care measures alone (n = 12). The primary objective was to determine difference in limb volume reduction for the two groups. Secondary objectives were to monitor change in other areas that impact BCRL: quality of life, arm function and range of shoulder movement. All 23 women completed the trial, providing full data for each time point. The intervention group showed a clinically and statistically significant improvement in relative ELV at week 26 (95 % confidence interval (CI) -26.57 to -5.12), whereas the control group improvement crossed the line of no effect (95 %CI -17.71 to 1.1). This study demonstrated the feasibility of conducting a RCT of exercise as a therapeutic intervention in the management of BCRL. Although the sample was small, the results support the findings of other exercise studies which have shown trends towards improvement.